Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Liver Cancer, Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/29/2018 |
| Start Date: | March 26, 2018 |
| End Date: | August 2020 |
Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion
Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic
randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC)
surveillance process completion among a socioeconomically and racially diverse cohort of
Texans with cirrhosis. Through this project the investigators will implement and evaluate
system-level mailed outreach interventions to identity at-risk patients with cirrhosis,
promote HCC surveillance, and ensure timely follow-up of tests at UT Southwestern (UTSW)
Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs
(VA) Medical Center. The study population will include adult patients with documented or
unrecognized cirrhosis and at least one outpatient clinic visit in year prior to
randomization. Patients will be identified using an EMR-enabled case identification
algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this
algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or,
mailed HCC surveillance outreach with patient education and patient navigation services
(Group 2).
randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC)
surveillance process completion among a socioeconomically and racially diverse cohort of
Texans with cirrhosis. Through this project the investigators will implement and evaluate
system-level mailed outreach interventions to identity at-risk patients with cirrhosis,
promote HCC surveillance, and ensure timely follow-up of tests at UT Southwestern (UTSW)
Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs
(VA) Medical Center. The study population will include adult patients with documented or
unrecognized cirrhosis and at least one outpatient clinic visit in year prior to
randomization. Patients will be identified using an EMR-enabled case identification
algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this
algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or,
mailed HCC surveillance outreach with patient education and patient navigation services
(Group 2).
Hepatocellular cancer (HCC) is the most common (≥ 95%) of liver cancers. HCC is also the
fastest rising cause of cancer-related deaths in the U.S. HCC is particularly important for
Texas residents. Texas has the second highest death rate from HCC in the nation. The 5-year
HCC survival remains low (10-15%) and most patients get diagnosed at late stages. Texas
residents notably Hispanics and African Americans are greatly affected with established HCC
risk factors including hepatitis C virus, hepatitis B virus and alcoholic liver disease.
Furthermore, emerging HCC risk factors, specifically the metabolic syndrome and non-alcoholic
fatty liver disease (NAFLD), are exceptionally common in Texans.
The goal of the Texas Hepatocellular Carcinoma Consortium (THCCC) is to reduce the death and
suffering related to liver cancer in Texas and the world through five research projects.
This protocol outlines Project 5 of the THCCC which is a comparative effectiveness randomized
controlled trial of strategies to increase HCC surveillance. This is the first multi-center
outreach intervention aimed at improving surveillance process completion among at-risk
patients with cirrhosis.
This study is based at 3 health systems in Texas: UT Southwestern (UTSW) Medical Center,
Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical
Center. Across these 3 sites, we will implement and evaluate system-level mailed outreach
interventions to identity at-risk patients with cirrhosis, promote HCC surveillance, and
ensure timely follow-up of tests. This study uses an EMR-enabled case-finding algorithm to
identify patients with documented cirrhosis, using ICD-9 codes, and those with unrecognized
cirrhosis, using laboratory data.
Over 3000 patients identified by this algorithm will be randomized to:
- Group 1: Usual care with opportunistic visit-based HCC surveillance.
- Group 2: Mailed HCC surveillance outreach with patient education and patient navigation
services.
The Specific Aims are:
- Aim 1: Compare the clinical effectiveness of the intervention strategies to increase
completion of the HCC surveillance process.
- Aim 2: Compare patient-reported satisfaction and acceptability of the HCC surveillance
strategies.
- Aim 3: Evaluate whether intervention effects are moderated by patient sex,
race/ethnicity, socioeconomic status, health care utilization, and documented vs.
unrecognized cirrhosis.
fastest rising cause of cancer-related deaths in the U.S. HCC is particularly important for
Texas residents. Texas has the second highest death rate from HCC in the nation. The 5-year
HCC survival remains low (10-15%) and most patients get diagnosed at late stages. Texas
residents notably Hispanics and African Americans are greatly affected with established HCC
risk factors including hepatitis C virus, hepatitis B virus and alcoholic liver disease.
Furthermore, emerging HCC risk factors, specifically the metabolic syndrome and non-alcoholic
fatty liver disease (NAFLD), are exceptionally common in Texans.
The goal of the Texas Hepatocellular Carcinoma Consortium (THCCC) is to reduce the death and
suffering related to liver cancer in Texas and the world through five research projects.
This protocol outlines Project 5 of the THCCC which is a comparative effectiveness randomized
controlled trial of strategies to increase HCC surveillance. This is the first multi-center
outreach intervention aimed at improving surveillance process completion among at-risk
patients with cirrhosis.
This study is based at 3 health systems in Texas: UT Southwestern (UTSW) Medical Center,
Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical
Center. Across these 3 sites, we will implement and evaluate system-level mailed outreach
interventions to identity at-risk patients with cirrhosis, promote HCC surveillance, and
ensure timely follow-up of tests. This study uses an EMR-enabled case-finding algorithm to
identify patients with documented cirrhosis, using ICD-9 codes, and those with unrecognized
cirrhosis, using laboratory data.
Over 3000 patients identified by this algorithm will be randomized to:
- Group 1: Usual care with opportunistic visit-based HCC surveillance.
- Group 2: Mailed HCC surveillance outreach with patient education and patient navigation
services.
The Specific Aims are:
- Aim 1: Compare the clinical effectiveness of the intervention strategies to increase
completion of the HCC surveillance process.
- Aim 2: Compare patient-reported satisfaction and acceptability of the HCC surveillance
strategies.
- Aim 3: Evaluate whether intervention effects are moderated by patient sex,
race/ethnicity, socioeconomic status, health care utilization, and documented vs.
unrecognized cirrhosis.
Inclusion Criteria:
- Adult patients (>21 years old)
- Documented cirrhosis
- Unrecognized cirrhosis
- An outpatient visit in year prior to randomization
- English or Spanish speaking
Exclusion Criteria:
- History of HCC
- History of liver transplantation
- Child Pugh C cirrhosis
- Significant comorbid conditions with life expectancy < 1 year, (e.g., extrahepatic
malignancy)
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